RCT of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion

NCT ID: NCT01982045

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2018-08-31

Brief Summary

The purpose of this study is to demonstrate the non-inferiority of AttraX® Putty as a bone graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar spine, in terms of efficacy and safety.

Detailed Description

Spinal fusion, a surgical procedure frequently used for many spinal conditions requiring stabilization of the vertebral column, is currently performed by using large amounts of autologous bone graft or autograft. A substitute for this patient own bone would eliminate the graft harvesting morbidity that is currently one of the main disadvantages. Recently, a promising synthetic graft substitute has been developed that has shown favorable results in pre-clinical studies. This product is AttraX® Putty (CE-557130), a bioresorbable tricalcium phosphate (TCP), mixed with a fast resorbing polymer carrier to improve surgical handling. The aim of the current study is to clinically investigate AttraX® Putty as an alternative to autologous bone graft in adult patients qualified for instrumented posterolateral fusion of the thoracolumbar spine (T10-S1).

The study design is a patient and observer blinded, controlled, randomized, multi-center clinical trial with intra-patient comparisons. This means that each patient is it owns control. According to a randomization scheme, one side of the spine will be grafted with AttraX® Putty the other side receives bone harvest from the iliac crest, which is currently the gold standard.

The primary outcomes of this study are the posterior spinal fusion rate after one year (based on CT-scans), and potential serious adverse events related with AttraX® Putty. Secondary outcomes are the resorption characteristics during the first year, volume of bridging bone mass after one year, evaluation of iliac crest pain, correlation of the posterior fusion rate to the presence of interbody fusion after one year and the posterior spinal fusion rate after two years.

Conditions

Spinal Deformity; Spinal Instability; Instrumented Spinal Fusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AttraX condition

8-10cc of AttraX® Putty per spinal level at the randomized allocation side of the spine (left or right).

Group Type: EXPERIMENTAL

AttraX® Putty

Intervention Type: DEVICE

Synthetic bone graft comprised of calcium phosphate granules and hydroxyapatite with an advanced biodissolvable polymer carrier that allows for better handling of the granules in putty form.

Autograft condition

8-10cc autologous bone graft per spinal level at the control side of the spine. This can be a combination of local bone and iliac crest bone, but at least 50% of the volume has to be iliac crest bone graft.

Group Type: ACTIVE_COMPARATOR

Autologous bone graft

Intervention Type: OTHER

Corticocancellous bone harvested from the iliac crest, with our without local bone obtained from decompression and/or preparation for fusion (facetectomy and denudement).

Interventions

AttraX® Putty

Synthetic bone graft comprised of calcium phosphate granules and hydroxyapatite with an advanced biodissolvable polymer carrier that allows for better handling of the granules in putty form.

Intervention Type: DEVICE

Autologous bone graft

Corticocancellous bone harvested from the iliac crest, with our without local bone obtained from decompression and/or preparation for fusion (facetectomy and denudement).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• To be treated with instrumented posterolateral thoracolumbar spinal fusion, with or without additional posteriorly inserted interbody devices (PLIF, TLIF), because of (1) deformity, (2) structural instability and/or (3) expected instability as a result of decompression for spinal stenosis;
• Non-responsive to at least 6 months of non-operative treatment prior to study enrollment;
• Fusion indicated for one or more levels in the T10 to S1/ilium region;
• Willing and able to understand and sign the study specific Patient Informed Consent;
• Skeletally mature between 18 and 80 years of age;

Exclusion Criteria

• Any previous surgical attempt(s) for spinal fusion (revision surgery);
• Previous treatments that compromise fusion surgery like irradiation;
• Previous autologous bone grafting procedures that compromise the quality and amount of iliac crest bone grafting;
• Indication for spinal fusion because of a traumatic reason, like a spinal fracture or traumatic instability;
• Active spinal and/or systemic infection;
• Spinal metastasis in the area intended for fusion;
• Systemic disease or condition, which would affect the subjects ability to participate in the study requirements or the ability to evaluate the efficacy of the graft (e.g. active malignancy, neuropathy);
• At risk to be non-compliant (e.g. (recently treated for) substance abuse, detainee, likely to immigrate);
• Participation in clinical trials evaluating investigational devices, pharmaceuticals or biologics within 3 months of enrollment in the study;
• Female patients who intend to be pregnant within 1.5 year of enrollment in the study;
• Body mass index (BMI) larger than 35 (morbidly obese);
• Being expected to require additional surgery to the same spinal region within the next 6 months;
• Current or recent (<1yr) corticosteroid use equivalent to prednisone ≥5mg/day, prescribed for more than 6 weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NuVasive

INDUSTRY

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

M.C. Kruyt, MD, PhD

Orthopaedic surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moyo Kruyt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Rijnstate Hospital

Arnhem, , Netherlands

Amphia Hospital

Breda, , Netherlands

University Medical Center Utrecht

Utrecht, , Netherlands

Countries

Netherlands

References

Lehr AM, Jacobs WC, Stellato RK, Castelein RM, Cumhur Oner F, Kruyt MC. Methodological aspects of a randomized within-patient concurrent controlled design for clinical trials in spine surgery. Clin Trials. 2022 Jun;19(3):259-266. doi: 10.1177/17407745221084705. Epub 2022 Mar 17.

Reference Type: DERIVED

PMID: 35297288 (View on PubMed)

Other Identifiers

NL44095.041.13

Identifier Type: -

Identifier Source: org_study_id